Study Evaluating Venetoclax in Subjects With Hematological Malignancies

AbbVie

Status and phase

Completed

Phase 2

Phase 1

Conditions

Small Lymphocytic Lymphoma (SLL)

Non-Hodgkin Lymphoma (NHL)

Acute Myeloid Leukemia (AML)

Multiple Myeloma (MM)

Chronic Lymphocytic Leukemia (CLL)

Treatments

Drug: azacitadine

Drug: rituximab / IDEC-C2B8

Drug: venetoclax

Study type

Interventional

Funder types

Industry

Identifiers

NCT02265731

M13-834

Details and patient eligibility

About

This study is evaluating the safety, pharmacokinetic profile and efficacy of venetoclax under a once daily dosing schedule in Japanese participants with hematological malignancies.

Enrollment

38 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Participants must have histologically documented diagnosis of NHL (and exhausted options considered standard of care) as defined in the World Health Organization classification scheme and relapsed following or be refractory to standard treatments such as R-CHOP, R-CVP, or fludarabine based regimens. Participants with other lymphoproliferative diseases can be considered in consultation with the AbbVie medical monitor
Relapsed or refractory multiple myeloma participants must have been previously treated with at least one prior line of therapy and have measurable disease
Chronic lymphocytic leukemia/small lymphocytic lymphoma participants must have relapsed or be refractory to standard treatments such as fludarabine based regimens or alkylator based regimens
Untreated AML subjects or Relapsed or refractory AML subjects must have been previously treated with at least one prior line of therapy
Eastern Cooperative Oncology Group (ECOG) performance score less than or equal to 1; adequate bone marrow independent of growth factor support per local laboratory reference range; and adequate coagulation, renal, and hepatic function, per laboratory reference range at Screening
Participants with a history of autologous or allogenic stem cell transplantation must have adequate blood counts independent of growth factor support and have recovered from any transplant-related toxicity(s) and be at least 100 days post-autologous transplant (multiple myeloma) or 6 month post-autologous transplant (NHL) prior to first dose of study drug or at least 6 months post-allogenic transplant (multiple myeloma) prior to first dose of study drug and not have active graft-versus-host disease (GVHD), i.e., requiring treatment

Exclusion criteria

NHL participants who have undergone an allogeneic stem cell transplant or were diagnosed with Post-Transplant Lymphoproliferative Disease, Burkitt's lymphoma, Burkitt-like lymphoma, or lymphoblastic lymphoma/leukemia
Participant tested positive for HIV
Participant has a cardiovascular disability status of New York Heart Association Class greater or equal to 2
Participant has a significant history of renal, neurologic, psychiatric, pulmonary, endocrinologic, metabolic, immunologic, cardiovascular, or hepatic disease that in the opinion of the Investigator would adversely affect his/her participating in this study.
Participant received a monoclonal antibody for anti-neoplastic intent within 8 weeks prior to the first dose of study drug.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

38 participants in 4 patient groups

Arm A (Phase 1)

Experimental group

Description:

Step-up doses of venetoclax to the designated cohort dose administered in participants with relapsed or refractory (R/R) Non-Hodgkin lymphoma (NHL) or multiple myeloma (MM)

Treatment:

Drug: venetoclax

Arm B (Phase 1)

Experimental group

Description:

Step-up doses of venetoclax to the designated dose administered in participants with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL)

Treatment:

Drug: venetoclax

Arm C (Phase 1)

Experimental group

Description:

Step-up doses of venetoclax to the designated dose with the addition of azacitidine administered in participants with acute myeloid leukemia (AML)

Treatment:

Drug: venetoclax

Drug: azacitadine

Arm D (Phase 2)

Experimental group

Description: